Catheter assembly with prosthesis crimping and prosthesis retaining accessories

ABSTRACT

A prosthesis retaining assembly for securing an implantable prosthesis to a catheter assembly can include a first member including a prosthesis retaining slot configured to retain a portion of the prosthesis. The retaining slot can have a first portion with a first width and a second portion with a second width. The first portion can be distal to the second portion. The second width can be larger than the first width, and the retaining slot can have an opening at a first surface of the first member. The prosthesis retaining assembly can also include a second member configured to be move relative to the first member. The second member can be configured to move to a position that obstructs a portion of the opening of the retaining slot.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.61/348,760 to Miller, filed May 27, 2010, the entire disclosure of whichis incorporated by reference in its entirety herein.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to catheter assemblies, crimpingaccessories, prosthesis retaining accessories and methods of crimpingprostheses onto a catheter and retaining the prostheses on a catheterduring delivery to a desired body location. More specifically, thepresent invention provides for catheters, crimping accessories, andretaining accessories that simplify the process of crimping a prostheticvalve to a catheter.

Background

Recently, minimally invasive approaches have been developed tofacilitate catheter-based implantation of valve prostheses on thebeating heart, intending to obviate the need for the use of classicalsternotomy and cardiopulmonary bypass. For example, French PatentApplication No. 99 14462 illustrates a technique and a device for theablation of a deficient heart valve by percutaneous route, with aperipheral valvular approach. International Application (PCT) Nos. WO93/01768 and WO 97/28807, as well as U.S. Pat. No. 5,814,097 to Stermanet al., U.S. Pat. No. 5,370,685 to Stevens, and U.S. Pat. No. 5,545,214to Stevens illustrate techniques that are not very invasive as well asinstruments for implementation of these techniques.

With regard to the positioning of a replacement heart valve, attaching avalve on a support with a structure in the form of a wire or network ofwires, forming a frame, has been proposed. This frame can be contractedradially in such a way that it can be introduced into the body of thepatient percutaneously by means of a catheter, and it can be deployed soas to be radially expanded once it is positioned at the desired targetsite. U.S. Pat. No. 3,657,744 to Ersek discloses a cylindrical,frame-supported, tri-leaflet tissue heart valve that can be deliveredthrough a portion of the vasculature using an elongate tool. The frameis mounted onto the expansion tool prior to delivery to the targetlocation where the frame and valve are expanded into place.

Current techniques for delivering prosthetic heart valves via a catheterinclude a transapical approach for aortic valve replacement, typicallyinvolving the use of an introducer port, i.e., a large-bore overtube, ofa trocar. A crimped, framed valve prosthesis reversibly coupled to adelivery catheter is transcatheterally advanced toward the native valve,where it is either forcefully deployed using a balloon catheter, or,alternatively, passively deployed using a self-expandable system.Accurate positioning of the replacement valve in the native annulus iscritical to the success of the implantation.

In order to prepare such valve prostheses for implantation, the valveprosthesis can be initially provided in an expanded or uncrimpedcondition, then crimped or compressed around the catheter until it is asclose to the diameter of the catheter as possible. Various methods anddevices are available for crimping the valve onto the catheter, whichmay include hand-held devices or tabletop devices, for example. Thesecrimping devices can initially provide an opening that is large enoughto accommodate a valve in its expanded condition and positioned over adesired section of a catheter. This valve can then be compressed byreconfiguring the opening of the crimping device in some way touniformly decrease the size of the opening until the valve is compressedto a desired size. However, crimping a prosthetic valve using known handheld or tabletop devices requires a user to assemble and position thecrimping device over a separately acquired catheter, resulting in thepossibility of user error. In addition, positioning a crimping deviceover a catheter assembly can be complicated, for example, where thecatheter assembly has a distal tip with a diameter larger than the finalcrimped diameter of the valve. In such situations, the known crimpingdevices are difficult to position on and remove from the catheter body.

The present invention provides a catheter assembly and crimpingaccessories for crimping a valve onto the catheter assembly. Crimpingaccessories according to the present invention can be providedpre-loaded onto a catheter assembly, and can be easily removed from thecatheter assembly after a prosthetic valve has been crimped onto thecatheter assembly, particularly with reference to catheter assemblieswith enlarged distal tips. The crimping accessories described herein canalso be provided separately from a catheter assembly and laterpositioned over the catheter. The catheter assemblies and associatedcrimping accessories described herein simplify the process of crimping aprosthetic valve and improve the accuracy of positioning the prostheticvalve within a body channel.

BRIEF SUMMARY OF THE INVENTION

The catheter assemblies and crimping accessories and methods describedherein seek to remedy one or more of the disadvantages of previouscrimping methods by providing catheters and crimping accessories thatsimplify the process of crimping a prosthetic valve or stent to acatheter. The crimping accessories and methods described herein areparticularly useful for crimping a prosthetic valve onto a catheterhaving a distal tip with a diameter larger than the final crimpeddiameter of the prosthetic valve. In one embodiment of the presentinvention, a catheter assembly includes a handle assembly located on theproximal end of the catheter assembly and a distal tip assembly locatedon the distal end of the catheter assembly. A crimping funnel isslidably positioned along the catheter. The crimping funnel includes adistal end having a first diameter and a proximal end having a seconddiameter smaller than the first diameter. An axial split is formed inthe proximal end. A first collar is provided encompassing a portion ofthe proximal end. The first collar is configured to hold the axial splitin the proximal end together when the first collar is at a first axiallocation along the proximal end, and to allow the axial split in theproximal end to open when the first collar is at a second axial locationalong the proximal end, such that the crimping funnel can be removedfrom the catheter assembly. Various prosthesis retaining assemblies tosecurely retain a prosthesis to a catheter assembly during delivery ofthe prosthesis to a desired body location are described herein.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying figures, which are incorporated herein, form part ofthe specification and illustrate embodiments of crimpers for prostheticvalves and methods of crimping and retaining prosthetic valves and otherprostheses for transcatheter delivery. Together with the description,the figures further serve to explain the principles of and to enable aperson skilled in the relevant art(s) to make and use the prostheticvalve crimpers and methods of crimping prosthetic valves fortranscatheter delivery described herein. In the drawings, like referencenumbers indicate identical or functionally similar elements.

FIG. 1 illustrates a catheter assembly in accordance with one embodimentpresented herein.

FIG. 2 is a depiction of one of the many types of prosthetic valves thatare compatible with the valve crimping accessories described herein. Theexemplary prosthetic valve is shown herein to facilitate explanation ofthe structure and operation of the crimping accessories and methodsdescribed herein.

FIG. 3 illustrates the catheter assembly of FIG. 1 including accessoriesfor crimping a prosthetic valve onto the catheter assembly.

FIG. 4 is a detailed view of the distal end of a funnel according to oneembodiment of the present invention.

FIG. 5 illustrates a catheter assembly with crimping accessories in onestage of the crimping process. At this stage, the crimping funnel hasbeen advanced over the prosthetic valve to crimp the valve.

FIG. 6 illustrates the distal end of a catheter assembly with crimpingaccessories in another stage of the crimping process. At this stage, thewire crimping hooks have been removed from the prosthetic valve and thewire loading ring has been retracted.

FIG. 7 illustrates the distal end of a catheter assembly with crimpingaccessories in another stage of the crimping process. At this stage, thecrimping funnel has been removed from the valve.

FIG. 8 illustrates the distal end of a catheter assembly with crimpingaccessories in another stage of the crimping process. At this stage, thefunnel collar has been moved to allow the proximal end of the funnel tosplit, allowing the funnel to be removed over the device tip.

FIG. 9 illustrates the distal end of a catheter assembly with crimpingaccessories in another stage of the crimping process. At this stage, thefunnel collar has been advanced over the distal tip of the catheterassembly.

FIG. 10 illustrates the distal end of a catheter assembly with crimpingaccessories in another stage of the crimping process. At this stage, thesupport arm sleeve has been retracted to cover the distal end of theprosthetic valve.

FIG. 11 illustrates the distal end of a catheter assembly with crimpingaccessories in another stage of the crimping process. At this stage, thewire loading ring has been removed from the catheter assembly and theintroducer has been advanced.

FIG. 12 illustrates a catheter assembly according to one embodiment ofthe present invention in a closed position after a prosthetic valve hasbeen loaded onto the catheter.

FIG. 13 illustrates an embodiment of a crimping funnel according toanother embodiment of the present invention.

FIG. 14 illustrates the crimping funnel of FIG. 13 with the distal andproximal collars displaced from their locked position.

FIG. 15 illustrates the crimping funnel of FIG. 13 in its open position.

FIG. 16 illustrates a catheter assembly according to another embodimentof the present invention including accessories for crimping a prostheticvalve onto the catheter assembly.

FIG. 17 is a detailed view of a valve retainer and capture sleeveaccording to one embodiment of the present invention.

FIG. 18 illustrates the valve retainer of FIG. 16 in an alternateposition.

FIG. 19 illustrates removal of the capture sleeve shown in FIG. 16 fromthe valve retainer.

FIG. 20 illustrates the distal end of a catheter assembly according toone embodiment of the present invention prior to loading a crimpingfunnel onto the assembly.

FIG. 21 illustrates the distal end of a catheter assembly according toone embodiment of the present invention with a crimping funnel loadedthereon.

FIG. 22 illustrates a catheter assembly with crimping accessories in onestage of the crimping process. At this stage, the crimping funnel hasbeen advanced over the prosthetic valve to crimp the valve.

FIG. 23 illustrates a valve retainer and capture sleeve according toanother embodiment of the present invention.

FIG. 24 illustrates a valve retainer according to another embodiment ofthe present invention.

FIG. 25 illustrates a valve retaining assembly according to anotherembodiment of the present invention.

FIG. 26 illustrates the valve retaining assembly of FIG. 25 in anexploded view.

FIG. 27 illustrates a cross-section of the valve retaining assembly ofFIG. 25.

FIG. 28 illustrates a cross-section of the valve retaining assembly ofFIG. 25 in a second position.

FIG. 29 is a perspective view of the valve retaining assembly of FIG. 25prior to mounting a prosthesis thereto.

FIG. 30 is a perspective view of the valve retaining assembly of FIG. 25at another stage of mounting a prosthesis thereto.

FIG. 31 is a perspective view of the valve retaining assembly of FIG. 25at another stage of mounting a prosthesis thereto.

FIG. 32 is a perspective view of the valve retaining assembly of FIG. 25with a prosthesis mounted thereto.

FIG. 33 is another perspective view of the valve retaining assembly ofFIG. 25 with a prosthesis mounted thereto.

FIG. 34 is a third perspective view of the valve retaining assembly ofFIG. 25 with a prosthesis mounted thereto.

FIG. 35 is a fourth perspective view of the valve retaining assembly ofFIG. 25 with a prosthesis mounted thereto.

FIG. 36 illustrates a valve retaining assembly according to anotherembodiment of the present invention.

FIG. 37 illustrates a cross-section of the valve retaining assembly ofFIG. 36.

FIG. 38 is a perspective view of the valve retaining assembly of FIG. 36at one stage of mounting a prosthesis thereto.

FIG. 39 is a perspective view of the valve retaining assembly of FIG. 36with a prosthesis mounted thereto.

FIG. 40A illustrates a valve retaining assembly according to anotherembodiment of the present invention.

FIG. 40B illustrates a first member of the valve retaining assembly ofFIG. 40A.

FIG. 40C illustrates a second member of the valve retaining assembly ofFIG. 40A.

FIG. 41 is a perspective view of the valve retaining assembly of FIG.40A.

FIG. 42 is a perspective view of the valve retaining assembly of FIG.40A with a prosthesis mounted thereto.

FIG. 43 is another perspective view of the valve retaining assembly ofFIG. 40A with a prosthesis mounted thereto.

FIG. 44 is a third perspective view of the valve retaining assembly ofFIG. 40A with a prosthesis mounted thereto.

FIG. 45 illustrates a valve retaining assembly according to anotherembodiment of the present invention.

FIG. 46 illustrates a cross-section of the valve retaining assembly ofFIG. 45.

FIG. 47 is a perspective view of the valve retaining assembly of FIG. 45at one stage of mounting a prosthesis thereto.

FIG. 48 is a perspective view of the valve retaining assembly of FIG. 45with a prosthesis mounted thereto.

FIG. 49 illustrates a valve retaining assembly according to anotherembodiment of the present invention.

FIG. 50 is an alternate view of the valve retaining assembly of FIG. 49showing the inside structure of the valve retaining assembly.

FIG. 51 is a perspective view of the valve retaining assembly of FIG.49.

FIG. 52 is a perspective view of the valve retaining assembly of FIG. 49at one stage of mounting a prosthesis thereto.

FIG. 53 is a perspective view of the valve retaining assembly of FIG. 49at another stage of mounting a prosthesis thereto.

FIG. 54 is a perspective view of the valve retaining assembly of FIG. 49at another stage of mounting a prosthesis thereto.

DETAILED DESCRIPTION OF THE INVENTION

The following detailed description of crimpers and retainers forprostheses and methods of crimping and retaining prostheses fortranscatheter delivery refers to the accompanying figures thatillustrate exemplary embodiments. Other embodiments are possible.Modifications can be made to the embodiments described herein withoutdeparting from the spirit and scope of the present invention. Therefore,the following detailed description is not meant to be limiting. Further,it would be apparent to one of skill in the art that the systems andmethods described below can be implemented in many different embodimentsof hardware. Any actual hardware described is not meant to be limiting.The operation and behavior of the systems and methods presented aredescribed with the understanding that modifications and variations ofthe embodiments are possible given the level of detail presented. Forexample, while the description provided is directed to accessories forcrimping and loading a prosthetic heart valve onto a catheter, thecrimping and retaining accessories described herein should not belimited to crimping and retaining of a prosthetic valve. One of skill inthe art would readily understand how to incorporate the features andstructures described herein into crimping and retaining accessories forother purposes. For example, features of the crimping and retainingaccessories described herein can be incorporated into catheters intendedfor other types of procedures, such as delivery of other implantableprostheses such as stents, valves, or other prostheses to a variety ofareas in the body.

FIG. 1 illustrates a catheter assembly 100 in accordance with oneembodiment presented herein. Catheter assembly 100 is depicted in FIG. 1in a closed configuration. Catheter assembly 100 generally includes ahandle assembly 102 located at the proximal end of the catheter, adistal tip assembly 104 located at the distal end of the catheter, andan introducer 116 slidably located along an outer delivery shaft 106between the distal tip assembly 104 and the handle assembly 102.

Outer delivery shaft 106 is preferably a tubular flexible braidedstructure. Outer delivery shaft 106 can be formed of braided materialfabricated from materials such as, but not limited to, polyethylenenaphthalate (PEN), polyester (PET), stainless steel, titanium, nitinol,cobalt nickel alloy, polyamide, polyimide, or the like. In someembodiments, outer delivery shaft may contain reinforcing materials orstructures. These structures can include an inner layer of polymeroverlaid by a first reinforcing braid layer, overlaid by a coilreinforcement, finally overlaid with an outside layer of polymericmaterial. In another embodiment, the inner layer of polymeric materialis overlaid by the coil reinforcement, which is overlaid by the braidedreinforcement, which is finally overlaid with the outside layer of apolymeric material. In other embodiments, the inner layer of polymericmaterial is overlaid by a braided layer, which is overlaid by the coilwinding, which is overlaid by another layer of braid, which is in turnoverlaid by an outer polymeric layer. Preferably, however, anyreinforcing layer used allows outer delivery shaft 106 to retain adegree of flexibility. Other suitable flexible materials can also beused to form outer delivery shaft 106 consistent with embodiments of thepresent invention.

Handle assembly 102 includes a main handle 108, a proximal control knob110, and a distal control knob 112. Main handle 108, a proximal controlknob 110, and distal control knob 112 can be formed of any suitablematerial. For example, in some embodiments the handle and control knobsare formed of a polymer material. Other materials are possible, as wouldbe understood in the art. A flushing port 114 can also be included onmain handle 108. Flushing port 114 can be used to de-air the catheterassembly. Also, the native annulus is exposed to the blood pressure in apatient's cardiovascular system during use of a heart valve deliverycatheter. As a consequence, in the absence of any counter pressure inthis annulus, blood can flow inside towards the proximal end of thecatheter, where it may coagulate and cause thrombosis. Thus, flushingport 114 can also allow fluid to be introduced into the native annulusto prevent such complications. In some embodiments, flush port 114 canalso be used for site specific drug delivery or to introduce radiopaquefluid into the body.

As will be described herein, proximal control knob 110, and distalcontrol knob 112 can be manipulated by a user in order to controloperation of the distal tip assembly 104 of catheters described herein.Distal tip assembly 104 includes a tip 122, which is preferably slottedfor the reasons described herein, a tip connector 124, and a support armsleeve 126. Support arm sleeve 126 defines an annular chamber. Aflushing tap 118 and a flushing tap lead 120 can be connected to anintroducer 116. Introducer 116 is preferably a tubular member that isslidably located over outer delivery shaft 106. Introducer 116 may beformed of a variety of materials, for example, stainless steel orvarious polymer materials. Catheter 100 is configured to be advancedalong a guide wire (not shown). Preferably, the catheter is advancedover a 0.035 inch guide wire. However, the dimensions of the cathetercomponents can be adjusted for advancement over guide wires with largeror smaller diameters.

Catheter assembly 100 further includes a valve retaining sleeve 130, avalve retaining sleeve connector 134, a valve retainer 132, and a tipguard 128. Valve retaining sleeve connector 134 secures valve retainingsleeve 130 to the distal end of the outer delivery shaft 106. The outerdelivery shaft 106 therefore extends from the interior of handleassembly 102 to sleeve connector 134. Slotted tip 122 and tip guard 128are positioned on and connected to the distal end of an intermediatedelivery shaft 132. Intermediate delivery shaft 132 extends from theinterior of handle assembly 102 to slotted tip 122, to which the distalend of intermediate delivery shaft 132 is attached. Intermediatedelivery shaft 132 is encompassed by outer delivery shaft 106 from theinterior of handle assembly 102 until the outer delivery shaft 106 endsat sleeve connector 134. Tip guard 128 is attached to the proximal endof slotted tip 122. In one embodiment, tip guard 128 can be attacheddirectly to intermediate shaft 132. Intermediate shaft 132 is preferablya tubular member.

It is understood that handle assembly 102 is merely an exemplaryembodiment of a catheter handle that can be used in conjunction with thecrimping devices and method described herein. The present invention isnot limited to catheters having handles such as those described herein.The crimping devices and methods described herein can be used withcatheter having different types of handles, including, e.g.,conventional hand controlled catheter handles. It is further understoodthat other devices described with reference to FIG. 1, but not essentialto the crimping devices and methods of the present invention, areoptional and can be replaced with similar devices or can be left outentirely if not necessary for a particular application. For example,depending on the delivery method, catheters assemblies for use with thecrimping devices and methods described herein can be provided without anintroducer.

A guide wire shaft is encompassed within intermediate shaft 132 andextends from the inside of handle assembly 102 to the proximal end ofslotted tip 122. Thus, in one embodiment of the present invention, atleast three shafts extend from the main handle, and the shafts arenested along at least a part of their lengths. Specifically, guide wireshaft 504 is encompassed by the intermediate delivery shaft 132 from aposition inside of handle assembly 102 to the interior of slotted tip122, which is preferably hollow through at least a portion thereof.Intermediate delivery shaft 132 is connected to, and ends, at theproximal end of slotted tip 122. In turn, intermediate delivery shaft132 is encompassed by the outer delivery shaft 106 from a positioninside of handle assembly 102 to the valve retaining sleeve connector134. Outer delivery shaft 106 is connected to, and ends, at theretaining sleeve connector 134. Intermediate shaft 132 and guide wireshaft can be constructed of various polymer materials, and may bebraided structures using materials described above with reference toouter delivery shaft 106.

FIG. 2 depicts an exemplary prosthetic heart valve 200. Heart valve 200is illustrated herein in order to facilitate description of the crimpingaccessories according to embodiments of the present invention. It isunderstood that any number of alternate prosthetic heart valves can beused with the crimping accessories described herein. Prosthetic heartvalve 200 is merely exemplary. Prosthetic heart valve 200 includessupport frame 202, valve leaflets 204 located towards the distal end ofsupport frame 202, valve skirt 206, and three fixation hooks 208extending from the proximal end of valve support 208.

Support frame 202 is preferably formed of a self-expanding material,e.g., nitinol. Other self-expanding or shape memory materials can beused instead of nitinol. Preferably, three valve leaflets 204 areprovided to form a tricuspid valve structure within prosthetic heartvalve 200. It is understood that alternate valve leaflet configurations,e.g., bicuspid valves, can be included in prosthetic heart valves foruse in conjunction with the crimping devices and methods describedherein. Leaflets 204 and skirt 206 are preferably formed of animalpericardium tissue, e.g., bovine pericardium or porcine pericardium. Inother embodiments, leaflets 204 and skirt 206 can be formed fromsynthetic materials. Leaflets 204 and skirt 206 are attached to supportframe 202, preferably using sutures, as shown in FIG. 2. It isunderstood that various types of sutureless bonding methods can be usedto attach leaflets 204 and skirt 206 to frame 202. Fixation hooks 208extend from the proximal end of support frame 202 and include eyelets attheir proximal end. Fixation hooks 208, which are optional, can beformed in various configurations other than that shown. For example,fixation hooks 208 can be J shaped hooks or eyelets, and fixation hooks208 can take on any number of sizes or shapes while remaining compatiblewith the crimping devices and methods described herein. Support frame202 further includes three support arms 210, which are attached tosupport frame 202 towards its distal end. Alternately, support arms 210can be formed integrally with support frame 202. Support arms 202 arepreferably formed of a self-expanding material, e.g., nitinol. Otherself-expanding or shape memory materials can be used instead of nitinol.Support arms 202 can be attached to support frame 202 such that they arebiased away from support frame 202 but can pivot radially with respectto support frame 202. A plurality of barbs 212 can be provided on theproximal end of support frame 202. Barbs 212 extend for a distancetowards the distal end of support frame 202. Preferably, barbs 212extend in an approximately axial direction. Barbs 212, which areoptional, can also be biased or curved slightly inward, but with lessinward curve than the surrounding section of support frame 202. Becausethe distal end of barbs 212 define a greater diameter than thesurrounding support frame, they receive the majority of forces when theproximal end of support frame 202 is crimped using the techniquesdescribed herein. This prevents damage to support frame 202 and, moreparticularly, to the sutures attaching skirt 206 to support frame 202.

FIG. 3 illustrates the catheter assembly 100 as shown in FIG. 1, furtherincluding accessories for crimping a prosthetic heart valve onto thecatheter assembly. Specifically, FIG. 3 depicts catheter assembly 100with a crimping funnel 302 loaded thereon. Crimping funnel 302 has asplit proximal end 304. A funnel collar 306 is threaded around splitproximal end 304 in order to hold split proximal end 304 together duringthe crimping process. Although FIG. 3 depicts funnel collar 306 securedto threads provided on the proximal end 304, it is understood that othermethods could be used to removably secure a funnel collar to crimpingfunnel 302. For example, removable clips could be used to secure thefunnel collars to crimping funnel 302. Alternately, sliding collarscould be used. A wire loading ring 308 is initially positionedproximally to the crimping funnel 302. Crimping wires 310 are connectedto wire loading ring 308 and extend distally through the funnel 302 andprotrude from the distal end of funnel 302. Each crimping wire 310 hasan eyelet hook 312 on the end thereof for securing the eyelets of avalve. For example, each eyelet 208 of prosthetic valve 200, shown inFIG. 2, can be connected to an eyelet hook 312 in order to a fix thevalve 200 in position for crimping. Crimping accessories shown in FIG. 3can be preloaded onto catheter assembly 100. It is understood that thecrimping accessories shown in FIG. 3 can be used with a variety ofexisting catheter assemblies other than those shown in the figures ofthe present application. Crimping funnel 302, funnel collar 306, andwire loading ring 308 can be formed of a variety of materials.Preferably, the crimping funnel 302, funnel collar 306, and wire loadingring 308 are formed generally of a polymer material.

FIG. 4 is a perspective view of the distal end of crimping funnel 302.As shown in FIG. 4, three clips 402 are provided on the inside of thedistal end of crimping funnel 302. When catheter assembly 100 withcrimping accessories loaded thereon is in the configuration shown inFIG. 3, each clip 402 retains one of the crimping wires 310. Such aconfiguration holds the crimping wires at a desired circumferentialposition. In operation, a prosthetic valve, such as valve 200 shown inFIG. 2, is loaded onto catheter assembly 100 when funnel 302 andcrimping wires 310 are generally in the position shown in FIG. 3. Atthis point eyelet hooks 312 are positioned distally of the valveretainer 136. Preferably, three crimping wires 310 are used. It isunderstood that one, two, or more than three crimping wires can beprovided, each corresponding to an eyelet 208 on a prosthetic valve tobe loaded onto the catheter assembly 100. Wire loading ring 308 ispreferably removably attached to introducer 116. As noted above,crimping wires 310 are connected wire loading ring 308. Therefore, wheneyelet hooks 312 are positioned within eyelets 208, valve 200 can beheld in a fixed axial position as funnel 302 is moved distally down thecatheter assembly 100.

FIG. 5 illustrates the distal end of catheter assembly 100 aftercrimping funnel 302 has been advanced distally down the catheterassembly. Because the prosthetic valve assembly 200 is held in place bythe crimping wires 310 as funnel 302 is forced distally down thecatheter assembly 100, the diameter of the prosthetic valve assembly 200is gradually decreased until the valve 200 is crimped and positionedsubstantially within the split proximal end 304 of crimping funnel 302.At this point the entire funnel 302 is positioned distally of valveretainer 136 and valve retaining sleeve 130. Eyelet hooks 312 ofcrimping wires 310 remain hooked in eyelets 208 of prosthetic valveassembly 200.

Eyelet hooks 312 are then removed from eyelets 208 of the prostheticvalve 200. The wire loading ring 308 is then retracted proximally alongthe catheter assembly 100. At this point outer delivery shaft 106 can beadvanced distally, thereby advancing valve retaining sleeve 130 over thecrimped valve, as shown in FIG. 6. As valve retaining sleeve isadvanced, its distal end primarily contacts barbs 212 of prostheticvalve assembly 200, thereby reducing friction that could be caused bythe inner surface of valve retaining sleeve 130 sliding over supportframe 202. This reduces damage to the support frame 202 and the suturessecuring the valve skirt 206 to the support frame 200. It is understoodthat the crimping methods described herein can be used to crimp valvesthat do not have barbs provided thereon. Alternate methods can be usedto prevent damage to support frame 202. For example, in otherembodiments, skirt 206 can be bonded to the interior of frame 202, orthe sutures securing the skirt to the frame can be secured to eyelets onthe interior of frame 202 or passages can be provided in frame 202 suchthat the sutures are not exposed on the exterior of frame 202. In suchembodiments, there is a reduced risk of damage to support frame 202 asthe valve retaining sleeve 130 is advanced over the prosthetic valveassembly 200.

As shown in FIG. 7, crimping funnel 302 is then advanced furtherdistally, such that the distal end of valve assembly 200 is no longerencompassed by the split proximal end 304 of the crimping funnel 302. Atthis point the eyelets 208 of valve prosthesis 200 would be retainedwithin valve retainer 136, as will be described in further detail withreference to FIGS. 17-18 and FIGS. 23-24. Furthermore, the proximal endof prosthetic valve assembly 200 is encompassed by valve retainingsleeve 130. The distal end of the prosthetic valve 200, includingsupport arms 210, protrude from the distal end of valve retaining sleeve130. At this position, support arms 210 are in the fully deployedposition. Support arm sleeve 126 and the remainder of distal tipassembly 104 is encompassed by crimping funnel 302.

Crimping funnel 302 is then removed from the catheter assembly bysliding it over distal tip assembly 104. Because the diameter of supportarm sleeve 126 is approximately equal to or slightly larger than thediameter of split proximal end 304 of funnel 302 when funnel collar 306is holding split proximal end 304 together, funnel collar 306 can bemoved distally down the split proximal end 304 of the funnel 302 toallow the two halves of the split proximal end 304 to split apart,thereby increasing the diameter of the split proximal end 304 to adiameter greater than that of support arm sleeve 126. Funnel 302 canthen be removed from the distal end of the catheter assembly 100, asshown in FIG. 9. At this point the distal end of prosthetic valve 200 isstill protruding from the distal end of valve retaining sleeve 130.

In order to capture and crimp the distal end of prosthetic valve 200,support arm sleeve 126 is retracted proximally along the catheter 100 toreach the position shown in FIG. 10. The proximal end of the support armsleeve 126 contacts the support arms 210 of prosthetic valve 200 therebycapturing the distal end of the prosthetic valve within support armsleeve 126 as shown in FIG. 10. Because the inner surface of support armsleeve 126 primarily contacts the supports arms 210, and not the mainbody of valve frame 202, damage to the valve frame 202 is reduced.

As shown in FIG. 11, wire loading ring 308 can then be detached fromintroducer 116 and removed over the distal tip assembly 104. Introducer116 can also be advanced distally to abut against the proximal end ofsupport arm sleeve 126, thereby covering valve retaining sleeve 130.FIG. 12 shows catheter assembly 100 in a closed configuration with theprosthetic valve loaded therein. The catheter can then be used todeliver prosthetic valve assembly 200 to a desired location in a body.

FIG. 13 shows another embodiment of a crimping funnel in accordance withthe present invention. Crimping funnel 1302 has two halves 1316 and1318, which are held together by two funnel collars, proximal collar1306 and distal collar 1314. Proximal collar 1306 is located at theproximal end 1320 of funnel 1302 and distal collar 1314 is located atthe distal end 1322 of funnel 1302. When used to crimp valve, funnel1302 is placed on a catheter such that the smaller diameter proximal end1320 is located proximally of the distal end 1322, in much the sameconfiguration as funnel 302 shown in FIG. 3. Preferably, both the distaland proximal ends of crimping funnel 1302 are threaded on their exteriorsurface. The interior surfaces of collars 1306 and 1314 preferably havecomplimentary threads formed thereon. As shown in FIG. 14, to allow thefunnel 1302 to split into its two halves 1316 and 1318, such that thefunnel is able to slide over distal tip assembly 104 as described abovewith reference to FIGS. 8-9, proximal funnel collar 1306 and distalfunnel collar 1314 are removed from crimping funnel 1302. Then, as shownin FIG. 15, the two halves 1316 and 1318 can be separated from eachother to create a larger gap. The crimping accessories can then beremoved over the distal tip 104 of catheter assembly 100.

In one embodiment, half 1316 can have a protrusion 1317, and half 1318can have a recess (not shown) that corresponds to protrusion 1317 ofhalf 1316. Protrusion 1317 can be seated within the recess of half 1318,preventing halves 1316 and 1318 from moving relative to each other in anaxial direction.

In another embodiment, crimping funnel 1302 can be provided with agradually decreasing diameter, similar to funnel 302 described above.The funnel can be provided with sections on each end with a diameterlarger than the diameter of the funnel surrounding those sections.Proximal collar 1306 and distal collar 1314 can be attached to theincreased diameter sections. In such embodiments, proximal collar 1306and distal collar 1314 be moved towards the center of the funnel insteadof being removed over the ends of the funnel. Because proximal collar1306 and distal collar 1314 have diameters greater than the sections ofthe funnel interior to the end sections, funnel 1302 can split, therebyreaching a greater diameter for removal over distal tip assembly 104,without removing collars 1306 and 1314 from the funnel.

Although FIGS. 13-15 illustrate proximal funnel collar 1306 and distalfunnel collar 1314 affixed to crimping funnel 1302 by the use ofcomplementary threads, it is understood that other methods can be usedto removably secure funnel collars 1306 and 1314 to crimping funnel1302. For example, clips could be used to secure the funnel collars tocrimping funnel 1302. Alternately, sliding collars could be used.

FIG. 16 illustrates an alternate embodiment of catheter assembly 100with crimping accessories mounted thereon. Instead of utilizing a wireloading ring to initially hold the prosthetic valve in place, theembodiment shown in FIG. 16 uses a modified valve retainer 1736, whichis described in detail with reference to FIGS. 17-18, surrounded by asleeve 1602. Catheter assembly 100 is otherwise identical to thecatheter assembly shown in FIGS. 1 and 3. As with the embodiment shownin FIG. 3, the crimping accessories included with catheter 100 include acrimping funnel 302 with a split proximal end 304 and a funnel collar306. As shown in FIG. 17, the eyelet capture sleeve 1602 is positionedaround valve retainer 1736. Capture sleeve 1602 is formed with an entrynotch 1702 at the distal end thereof, as shown in FIG. 17. Threeretainer slots 1704 are formed in the outer perimeter of the distal endof valve retainer 1736. Retainer slots 1704 correspond to the threeeyelets 208 of prosthetic valve 200, which were described in furtherdetail above with regards to FIG. 2. Although not illustrated in FIG.17, a circumferential channel extends around the circumference of valveretainer 1736 proximately to retainer slots 1704, much like channel 2402shown in FIG. 24 with the respect to an alternate embodiment of a valveretainer. To load prosthetic valve 200 into valve retainer 1736, oneeyelet 208 is first inserted through entry notch 702 and into a retainerslot 1704. As shown in FIG. 2, eyelets 208 are formed in generally aT-shape with the proximal end of the eyelet being wider than the face ofthe eyelet. Retainer slots 1704 are narrower than the proximal ends ofeyelets 208. After the first eyelet has been inserted into the firstretainer slot, the capture sleeve 1502 is rotated such that the firstretainer slot is no longer aligned with entry notch 1702. Because theproximal end of the first eyelet 208 is wider than the retainer slotopening 1704, the first eyelet 208 is held inside the capture sleeve1502. This process is then repeated for the remaining eyelets 208 suchthat all eyelets are secured within the capture sleeve 1502 and valveretainer 1736. FIG. 18 shows valve retainer sleeve 1736 and sleeve 1602in a position where the capture sleeve 1602 has been rotated such thatthe entry notch 1702 is not aligned with either of the three retainerslots 1704.

After all three eyelets 208 are secured inside the valve retainer 1736,the valve retaining sleeve 130 can be advanced underneath the capturesleeve 1602 and over valve retainer 1736, as shown in FIG. 19. Aftervalve retaining sleeve 130 is fully advanced over the valve retainer1736, the capture sleeve is no longer needed to retain eyelets 208within valve retainer 1736. Capture sleeve 1602 can then be removed bysliding the sleeve distally off of the valve retaining sleeve 130. Inorder to remove capture sleeve 1602 from the distal end of the catheterassembly 100, the capture sleeve 1602 may need to be split for removalfrom the catheter assembly because its internal diameter is smaller thanthat of the distal tip of catheter assembly 100. Capture sleeve 1602 maybe pre-slit in the manner described above with reference to crimpingfunnel 1302. One or more collars can be used to secure the two halves ofcapture sleeve 1602 together prior to removal from the catheter assembly100. As with crimping funnel 1302, the collars can be clips or slidingsnap-on collars, or can be threaded. Alternately, capture sleeve 1602can be formed of a single piece and can be manually cut and removedafter a use.

After the capture sleeve 1602 is removed from the catheter assembly 100,the distal end of the catheter assembly 100 will be in the positionillustrated in FIG. 20. Although prosthetic valve 200 is not depicted inFIG. 20, at this point the eyelets 208 of prosthetic valve 200 would beretained within valve retainer 1736 and the remainder of prostheticvalve 200 would be extending from the distal end of capture sleeve 130.Furthermore, although crimping funnel 302 is not shown in FIG. 20 itwould at this time be positioned proximally of valve retaining sleeve130, as shown in FIG. 16. Because the valve retainer 1736 is fixed tothe intermediate shaft 132, the valve retainer serves to hold prostheticvalve assembly 200 in place as the crimping funnel is advanced over thevalve assembly 200.

Specifically, as shown in FIG. 21, the crimping funnel 302 is advanceddistally while eyelets 208 of valve assembly 200 are retained withinvalve retainer 1736. After the prosthetic valve assembly 200 has beencrimped to its delivery diameter and is housed within the split proximalend 304 of funnel 302, the sleeve 130 is advanced over the crimped valveas shown in FIG. 22. Crimping funnel 302 is then removed from thecatheter assembly in the manner described above with reference to FIGS.7-10. Catheter assembly 100 can then be moved to its closed position byadvancing introducer 116 to abut against the proximal end of support armsleeve 126 as shown in FIG. 12.

FIG. 23 illustrates another embodiment of a valve retainer according tothe present invention. Valve retainer 2336 is configured to be operatedwithout the need for a separate capture sleeve. Slots 2304 are opened tocentral lumen 2306. This configuration allows eyelets 208 to be loadedinto retainer slots 2304 from the inside of central lumen 2306, therebyavoiding the need for a notch in the outer sleeve to allow introductionof the eyelets 208 into the retainer slots 2304. As a result, valveretainer 2336 can be used with valve retaining sleeve 130, eliminatingthe need for a separate capture sleeve and saving the user from thenecessity of removing the capture sleeve after loading the valve.

FIG. 24 illustrates another embodiment of a valve retainer according tothe present invention. Valve retainer 2436 has a plurality of retainerslots 2404, a circumferential channel 2402 beneath the retainer slots2404, and a central lumen 2406 to receive intermediate delivery shaft132. As seen in FIG. 24, the interior of retainer slots 2404 is widerthan the portion of retainer slots 2404 opened to the outside of valveretainer 2436. This feature allows valve retainer 2436 to be usedwithout the necessity of a separate capture sleeve. To load a prostheticvalve into valve retainer 2436, the ends of eyelets 208 are firstinserted into the wider interior portion of slots 2404. The ends ofeyelets 208 can then be moved towards the exterior of retainer slots2404, such that the larger end of eyelets 208 are prevented from passingthrough the narrower portions of retainer slots 2404. Although not shownin FIG. 24, valve retainer 2436 would be encompassed by valve retainingsleeve 130 when eyelets 208 are loaded into the retainer. Therefore,eyelets 208 would be prevented from escaping the valve retainer bypassing out of the retainer slots 2404 towards the exterior of valveretainer 2436. In addition, because valve 200 is preferably formed of aself expanding material, e.g., nitinol, the eyelets 208 are naturallypressed outward against valve retaining sleeve 130.

FIG. 25 illustrates another embodiment of a valve retaining assemblyaccording to the present invention. Valve retaining assembly 2500includes a housing member 2508 and a blocking member 2502. Blockingmember 2502 is slidably located within housing member 2508. Retainerslots 2504 are provided on the top perimeter of housing member 2508. Acentral lumen 2506 extends through the blocking member 2502 and therebythrough the housing member 2508. Central lumen 2506 can receive adelivery shaft therethrough. Valve retaining assembly 2500 also includesguide pins 2512 whose function is detailed with respect to FIGS. 27 and28 herein. A spring 2514 is also included. Although spring 2514 isillustrated as a coil spring, other types of springs can be used invalve retaining assembly 2500 in place of or in addition to the coilspring. For example, any type of mechanical spring can be used, ormultiple smaller mechanical springs can be used. Spring 2514 can also beformed of a resilient material, such as silicon. Blocking member 2502 issecured to a base 2516.

FIG. 26 is an exploded view of valve retaining assembly 2500. As seen inFIG. 26, blocking member 2502 further includes two vertical channels2602. Guide pins 2512 extend through housing member 2508 into verticalchannels 2602. The interaction of guide pins 2512 and vertical channels2602 allows vertical movement of blocking member 2502 with respect tohousing member 2508 while preventing rotational movement of blockingmember 2502 with respect to housing member 2508. Base 2516 has a screwtop for securing the blocking member 2502 thereto. However, it isunderstood that various alternate methods could be used to affixblocking member 2502 to base 2516. For example, snap-lock or ratchetingsystems can be used to attach blocking member 2502 to base 2516.

FIG. 27 is a cross-sectional view of valve retaining assembly 2500 inthe position shown in FIG. 25. As seen in FIG. 27, when blocking member2502 is in its fully down position with respect to housing member 2508,the top of blocking member 2502 is flush with the top of housing member2508. The directional orientation terms used herein to facilitatedescription of embodiments of the present invention, for example, fullydown, upwards, downwards, upwardmost, downwardmost, etc, refer to thevarious assemblies and members as they are oriented in the respectivefigures. Other orientations may be used without departing from the scopeof the present invention.

FIG. 28 shows valve retaining assembly 2500 with the blocking member inits upwardmost position with the respect to housing member 2508. Asshown in FIG. 28, when blocking member 2502 is in this upwardmostposition, spring 2514 is compressed. Thus, blocking member 2502 isbiased to the position shown in FIG. 27, and reaches the position shownin FIG. 28 when force is applied to the spring 2514. The position shownin FIG. 28 allows fixation hooks 208 of a prosthetic valve 200 to befitted within retainer slots 2504, as shown in FIG. 29. Although valveretaining assembly 2500 is described herein with reference to prostheticvalve 200 for ease of description, it is understood that otherprosthetic valves can be used in conjunction with valve retainingassembly 2500. Other prostheses such as stents, grafts, and other typesof prostheses may also be used in conjunction with all embodiments ofvalve retainers and valve retaining assemblies described herein.

As shown in FIG. 29, valve retaining assembly 2500 also includes anouter tube 2902 that can be positioned around housing member 2508. Whenouter tube 2902 is positioned as shown in FIG. 29, the outside openingsof retainer slots 2504 are covered by the top portion of outer tube2902. A prosthetic valve 200 is advanced towards the valve retainingassembly 2500 is shown in FIG. 29. Prosthetic valve 200 is already inits crimped position, although the crimping process is not illustratedin FIG. 29. It is understood that prosthetic valve 200 can be crimpedaccording to any of the methods described in the present application.Other crimping systems and methods known in the art can also be used tocompress prosthetic valve 200 to its reduced-diameter position forattachment to a valve retainer or valve retaining assembly. Prostheticvalve 200 can also be provided to a user in its crimped position,thereby eliminating the need for on-site crimping.

As shown in FIG. 29 prosthetic valve 200 is advanced towards valveretaining assembly 2500. Blocking member 2502 is attached to a fixationshaft 2904 that is connected at an opposite end to a point within thecatheter handle, and is thereby held static. Alternately, a catheterhandle can be provided with controls that allow for controlled movementof fixation shaft 2904. Preferably, such controls have the ability tolock fixation shaft 2904 in a static position if such controls areprovided. At this point in the attachment process, valve retainingassembly 2500 is in the position described and shown with reference toFIG. 28, that is, the blocking member 2502 is in its upwardmost positionwith respect to housing member 2508 and spring 2514 is compressed. Valveretaining assembly 2500 can be forced into this position by pinchingouter tube 2902 and housing member 2508, thereby creating frictionbetween outer tube 2902 and housing member 2508, and then pulling bothouter tube 2902 and housing member 2508 downward, away from prostheticvalve 200 in FIG. 29. This forces downward movement of housing member2508 relative to blocking member 2502, thereby compressing spring 2514and resulting in blocking member 2502 reaching its uppermost positionwith respect to housing member 2508.

As shown in FIG. 30, prosthetic valve 200 is advanced to valve retainingassembly 2500. As shown in FIGS. 31-32, fixation hooks 208 of prostheticvalve 200 are placed within valve retainer slots 2504 from the inside ofhousing member 2508. As best seen in FIG. 32, blocking member 2502 is inits upwardmost position allowing fixation hooks 208 to be placed inretainer slots 2504 from the inside. Because outer tube 2902 covers theexterior opening of retainer slots 2504, fixation hooks 208 are held inplace in retainer slots 2504. Each of the fixation hooks 208 ofprosthetic valve 200 are inserted into their respective retainer slots2504 in a similar manner. It is understood that prosthetic valve 200 canbe formed with any number of fixation hooks 208, and that valveretaining assembly 2500 can be formed with a corresponding number ofretainer slots 2504. When the fixation hooks 208 are housed withinretainer slots 2504, the prosthetic valve 200 is in the position shownin FIG. 31. During this entire procedure friction should be kept betweenouter tube 2902 and housing member 2508 by clamping or pinching theouter tube 2902 and housing member 2508. This clamping can be achieved,for example, with a clamping tool or with a user's fingers.

Once all fixation hooks 208 are secured within retainer slots 2504,outer tube 2902 and housing member 2508 are moved upwards while stillmaintaining pressure or friction between those two components so thathousing member 2508 moves upwards with respect to blocking member 2502.Blocking member 2502 is connected to the fixation shaft 2904, which isheld static, and therefore blocking member 2502 does not move when outertube 2902 and housing member 2508 are slid upwards along the axis of thedelivery shaft.

When outer tube 2902 and housing member 2508 reach their upwardmostposition, that is, when the top of outer tube 2902 and the top ofhousing member 2508 are flush with the top of blocking member 2502, thepressure between outer tube 2902 and housing member 2508 can bereleased. This position is shown in FIG. 33.

Because, as best seen in FIGS. 25-28, the top portion 2803 of blockingmember 2502 has a larger diameter than the lower portion of blockingmember 2502, the top portion 2803 of blocking member 2502 fits snugglyagainst the interior opening of retainer slots 2504 when blocking member2502 is in its fully down position. As a result, when valve retainingassembly 2500 is in the position shown in FIG. 33, fixation hooks 208within retainer slots 2504 are prevented from escaping to the inside ofhousing member 2508 by the top portion 2803 of blocking member 2502,while fixation hooks 208 are prevented from exiting the exterior openingof retainer slots 2504 by outer tube 2902. Outer tube 2902 can then beadvanced upward over the prosthetic valve 200 as shown in FIG. 34.

FIG. 35 depicts valve retaining assembly 2500 with a prosthetic valve200 mounted thereto with outer tube 2902 fully advanced to entirelycover the prosthetic valve 200. In this configuration, prosthetic valve200 can be delivered to a desired body location.

Thus, once fixation hooks 208 are positioned within retainer slots 2504,the eyelets are prevented from escaping from the exterior opening ofretainer slots 2504 and the interior opening of retainer slots 2504.Specifically, the interior opening of retainer slots 2504 is obstructedby blocking member 2502, and the exterior opening of retainer slots 2504is obstructed by outer tube 2902. The terms obstruct, obstructed, orobstructing, as used with reference to the various embodiments of thepresent invention described herein, are intended to mean covering asufficient amount of an opening so as to prevent fixation hooks 208 ortheir equivalent from exiting the retainer slots 2504. In oneembodiment, outer tube 2902 can be configured similar to sleeve 1602 asdescribed regarding FIG. 16.

FIGS. 36-39 illustrate another embodiment of a valve retaining assembly3600. FIG. 36 illustrates another embodiment of a valve retainer. Valveretainer 3636 can have a central lumen 3606 extends through the centerof valve retainer 3636. Three retainer slots 3604 are provided aroundthe upper perimeter of valve retainer 3636. Three upwardly extendingwalls 3618 are positioned between the retainer slots 3604.

FIG. 37 shows valve retainer 3636 at the distal end of a deliverysystem. As shown in FIG. 37, an outer tube 3702 is positioned aroundvalve retainer 3636. Valve retainer 3636 is secured to a fixation shaft3704.

FIG. 38 illustrates a method by which a prosthetic valve 200 can besecured within valve retainer 3636. Specifically, a prosthetic valve 200in its crimped configuration is advanced towards valve retainer 3636.Fixation hooks 208 of prosthetic valve 200 are inserted within lumen3606 and inside extending walls 3618. The top of outer tube 3702 isflush with the top shoulder 3820 of valve retainer 3636, excludingextending walls 3618. Thus, when fixation hooks are inserted intoretainer slots 3604 they are prevented from exiting the outside ofretainer slots 3604. In one embodiment, prosthetic valve 200 ispre-biased to an expanded position such that when fixation hooks 208 areinserted into retainer slots 3604 and pressure is released fromprosthetic valve 200, the fixation hooks 208 are naturally forcedagainst the outer tube 3702 by the pre-bias of prosthetic valve 200.

FIG. 39 illustrates a prosthetic valve 200 fully attached to valveretainer 3636. As shown in FIG. 39, once all fixation hooks 208 arefully placed within retainer slots 3604 the diameter of prosthetic valve200 is allowed to expand slightly. Because prosthetic valve 200 has aslightly larger diameter in this configuration, the cells 3902 ofprosthetic valve 200 are also slightly larger. As a result, whenprosthetic valve 200 is in this configuration, cells 3902 can no longerfit through the inside of retainer slot 3604 because of the expansion ofthe outer perimeter of cells 3902. The outer perimeters of the expandedcells 3902 abut against the extending walls 3618. The fixation hooks 208are prevented from escaping from the outside of retainer slots 3604 byouter tube 3702. Outer tube 3702 can then be advanced to cover theprosthetic valve 200 completely, and thereafter delivered to a desiredbody location. After the prosthetic valve 200 is delivered to a desiredbody location, outer tube 3702 can be slid downward off the prostheticvalve 200, allowing fixation hooks 208 to escape from the outside ofretainer slots 3604, and thereby allowing prosthetic valve 200 to deployin a body lumen to its pre-biased expanded shape. Generally, deploymentof the prosthetic valve 200 is achieved in the same manner with theother embodiments of valve retainers and valve retaining assembliesdescribed herein. In one embodiment, outer tube 3702 can be configuredsimilar to sleeve 1602 as described regarding FIG. 16.

FIGS. 40A, 40B and 40C illustrate another embodiment of a valveretaining assembly according to the present invention. Valve retainingassembly 4000 includes a blocking member 4002 and a housing member 4008.In one embodiment, blocking member 4002 includes one or more upper tabs4020, one or more lower tabs 4024, a ridge 4030 approximately mid-waydown blocking member 4002, and one or more recesses 4026. In oneembodiment, housing member 4008 includes one or more retainer slots4004, one or more upper channels 4018, one or more lower channels 4022,and one or more flanges 4028. It is understood that the specific numberof upper tabs 4020, lower tabs 4024, recesses 4026, upper channels 4018,lower channels 4022, and flanges 4028 can vary in other embodiments ofthe present invention.

In one embodiment, housing member 4008 can slide over blocking member4002 until flanges 4028 are even with blocking member recesses 4026.Recesses 4026 are approximately the same size as flanges 4028 so thatflanges 4028 fit securely within recesses 4026. In one embodiment,flanges 4028 can be biased inward. Lower tabs 4024 of blocking member4002 also fit within lower channels 4022 of housing member 4008 toprevent rotation of housing member 4008 relative to blocking member4002.

FIG. 41 illustrates an outer tube 4102 positioned over valve retainingassembly 4000. Outer tube 4102 covers the outside of valve retainerslots 4004. While the valve retaining assembly 4000 is in thisconfiguration, a prosthetic valve 200 is advanced towards the valveretaining assembly 4000 and fixation hooks 208 are inserted intoretainer slots 4004 from the inside of housing member 4008, as shown inFIG. 42. Outer tube 4102 prevents fixation hooks 208 from escaping fromthe outside of retainer slots 4004. Once fixation hooks 208 are securedwithin retainer slots 4004, housing member 4008 and outer tube 4102 aresimultaneously pushed upward towards prosthetic valve 200. In order toachieve this simultaneous movement pressure must be applied to outertube 4102 in the area of housing member 4008 to create friction betweenouter tube 4102 and housing member 4008. As shown in FIGS. 43 and 44,forcing outer tube 4102 and housing member 4008 upward causing flanges4028 of housing member 4008 to exit from recesses 4026 of blockingmember 4002. Housing member 4008 and outer tube 4102 are advancedupwardly along blocking member 4002 until flanges 4028 of housing member4008 snap into place above ridge 4030 of blocking member 4002. Upperchannels 4018 of housing member 4008 receive upper tabs 4020 of blockingmember 4002 in order to prevent rotation of blocking member 4002relative to housing member 4008. Once housing member 4008 is fullyadvanced over blocking member 4002, fixation hooks 208 are preventedfrom exiting from the inside of retainer slots 4004 because the insideof retainer slots 4004 abut directly against the upper surface ofblocking member 4002. Fixation hooks 208 are prevented from exiting theoutside of retainer slots 4004 by outer tube 4102. Outer tube 4102 canthen be advanced fully over prosthetic valve 200 for delivery to adesired location in a body. Outer tube 4102 can then be removed todeploy prosthetic valve 200. In one embodiment, outer tube 4102 can beconfigured similar to sleeve 1602 as described regarding FIG. 16.

FIG. 45 illustrates a valve retaining assembly 4500 according to anotherembodiment of the present invention. Valve retaining assembly 4500includes a main body 4502 with retainer slots 4504 formed therein.Retracting rods 4518 extend into retainer slots 4504. A central lumen4506 extends through the center of main body 4502. Valve retainingassembly 4500 also includes a middle ring 4520 and a bottom ring 4522.

FIG. 46 is a cross-section of valve retaining assembly 4500. As shown inFIG. 46, a disk 4602, which is preferably constructed of silicon, ispositioned above the bottom surface 4603 of bottom ring 4522 and insidethe cylindrical wall 4605 of bottom ring 4522. Main body 4502 extendsinside both middle ring 4520 and bottom ring 4522. Bases 4606 of theretracting rods 4518 have a slightly larger diameter than the remainderof retracting rods 4518 such that the bottom of main body 4502 is spacedfrom the top of disk 4602 by the base 4606 of retracting rods 4518. Inone embodiment, disk 4602 is compressible and resilient such that it canfunction as a spring when pressure is applied to the disk 4602. Althoughdisk 4602 is shown, it is understood that other types of springs may beused to pre-bias retracting rods 4518 upwards into the position shown inFIG. 46. For example, a traditional coil spring or a plurality of coilsprings can be used. Other types of mechanical springs can also be used.Disk 4602 can be formed of any other suitable, compressible andresilient material.

As shown in FIG. 47, an outer tube 4702 is positioned around main body4502, middle ring 4520, and bottom ring 4522. To insert prosthetic valve200 into the valve retaining assembly 4500, fixation hooks 208 arepressed downward against the top of retracting rods 4518. This downwardpressure on retracting rods 4518 compresses the disk 4602 which allowsthe retracting rods 4518 to move out of retainer slots 4504. Fixationhooks 208 can be forced to the bottom of retainer slots 4504, andthereby self-expand into the outside opening of retainer slots 4504because of the pre-bias of prosthetic valve 200. This configuration isshown in FIG. 48. Because the prosthetic valve 200 is pre-biased into anexpanded position, once fixation hooks 208 reach the bottom of retainerslots 4504, fixation hooks 208 naturally expand into the outside openingof retainer slots 4504 and against outer tube 4702. After fixation hooks208 are positioned against outer tube 4702, retracting rods 4518 returnto their original upwardly biased position because there is no longerpressure on top of the retracting rods 4518 to compress disk 4602. Thus,the fixation hooks 208 are prevented from exiting the inside of retainerslots 4504 by the retracting rods 4518. Outer tube 4702 can then be slidcompletely over prosthetic valve 200 for delivery to a desired bodylocation. Outer tube can then be removed to allow fixation hooks 208 toexit the outside of retainer slots 4504, thereby allowing prostheticvalve to assume its pre-biased expanded configuration. In oneembodiment, outer tube 4702 can be configured similar to sleeve 1602regarding FIG. 16.

FIG. 49 depicts another embodiment of a valve retaining assemblyaccording to the present invention. Valve retaining assembly 4900includes a blocking member 4902 and a housing member 4908. Both blockingmember 402 and housing member 4908 have retainer slots. Blocking memberretainer slots 4904 are aligned with housing member retainer slots 4910when valve retaining assembly 4900 is in the configuration show in FIG.49. A central lumen 4906 extends through the center of blocking member4902. Guide pins 4912 extend through holes in housing member 4908.

FIG. 50 is an inside view of valve retaining assembly 4900 when thehousing member 4908 and blocking member 4902 are oriented as shown inFIG. 49. As shown in FIG. 50, valve retaining assembly 4900 includes atorsion spring 5002. A plurality of rods 5004 are positioned undertorsion spring 5002 to secure torsion spring 5002 in place relative tohousing member 4908. Torsion spring 5002 provides a rotational bias toblocking member 4902 rather than biasing blocking member 4902 up or downrelative to housing member 4908. Channels 5006 in blocking member 4902receive guide pins 4912 therein. The cooperation of guide pins 4912 andchannels 5006 limits the range of rotation of blocking member 4902relative to housing member 4908, and also prevents vertical movement ofblocking member 4902 relative to housing member 4908.

FIG. 51 shows valve retaining assembly 4900 in place over a deliveryshaft. In the configuration shown in FIG. 51, valve retaining assembly4900 is in a first position. An outer tube 5102 is positioned aroundhousing member 4908. As shown in FIG. 51, blocking member 4902 has beenrotated with respect to housing member 4908 such that blocking memberretainer slots 4904 are not aligned with housing member retainer slots4910. Torsion spring 5002 biases blocking member in this position. Outertube 5102 covers the outside of housing member retainer slots 4910.While valve retaining assembly 4900 is in this configuration, theprosthetic valve 200 is advanced towards valve retaining assembly 4900and fixation hooks 208 of prosthetic valve 200 are inserted into theblocking member retainer slots 4904 from the inside of blocking member4902. After all fixation hooks 208 have been inserted into a blockingmember retainer slot 4904, the user can rotate prosthetic valve 200against the biasing force of torsion spring 5002 in order to bringblocking member retainer slots 4904 into alignment with housing memberretainer slots 4910. Because prosthetic valve 200 is biased in anexpanded position, once blocking member retainer slots 4904 are alignedwith housing member retainer slots 410, fixation hooks 208 will pop outinto housing member retainer slots 4910 until they press against outertube 5102. In addition, because torsion spring 5002 biases the rotationof blocking member 4902 compared with housing member 4908 to the firstposition (shown in FIG. 51), when fixation hooks 208 exit blockingmember retainer slots 4904, blocking member 4902 is pulled back to thefirst position by torsion spring 5002. That is, because of the naturalbias of torsion spring 5002, torsion spring 5002 rotates blocking member4902 back to a position wherein the blocking member retainer slots 4904are not aligned with housing member retainer slots 4910. Fixation hooks208 are thereby prevented from exiting the inside of housing memberretainer slots 4910 by the walls of blocking member 4902 and fixationhooks 208 are prevented from exiting the outside of housing memberretainer slots 4910 by outer tube 5102. With reference to FIG. 50, theinteraction of channels 5006 and guide pins 4912 limits the range ofrotation of blocking member 4902 such that over rotation is not allowed.After fixation hooks 208 are secured within housing member retainerslots 4910 and blocking member 4902 has rotated back to its originalstarting position, outer tube 5102 can be advanced over prosthetic valve200 and valve 200 can be delivered to a desired body location. Outertube can then be removed to allow fixation hooks 208 to exit the outsideof retainer slots 4504, thereby allowing prosthetic valve to assume itspre-biased expanded configuration. In one embodiment, outer tube 5102can be configured similar to sleeve 1602 in FIG. 16.

Preferably, the entire process, including securing a valve assembly to aloading ring or valve retainer, crimping the valve assembly, removingthe crimping accessories from the catheter assembly, and moving thecatheter assembly 100 to its closed configuration, is performed in asaline bath by a user.

The foregoing description of the invention has been presented forpurposes of illustration and description. It is not intended to beexhaustive or to limit the invention to the precise form disclosed.Other modifications and variations may be possible in light of the aboveteachings. The embodiments and examples were chosen and described inorder to best explain the principles of the invention and its practicalapplication and to thereby enable others skilled in the art to bestutilize the invention in various embodiments and various modificationsas are suited to the particular use contemplated. It is intended thatthe appended claims be construed to include other alternativeembodiments of the invention.

EXAMPLES

The following paragraphs serve as examples of the above-describedembodiments.

Example 1

One embodiment of the present invention provides a prosthesis retainingassembly for securing an implantable prosthesis to a catheter assembly.The prosthesis retaining assembly comprises a blocking member having acentral lumen and a housing member connected to the blocking member. Aplurality of prosthesis retaining slots is formed in the housing member.The blocking member is positioned inside the housing member and theblocking member is movable relative to the housing member. Theprosthesis retaining slots are configured to retain a portion of aprosthesis therein.

The prosthesis retaining assembly can include an outer tube surroundingthe housing member. The prosthesis retaining assembly can include abiasing member connected to the blocking member and the housing member,wherein the biasing member biases the blocking member to a firstposition relative to the housing member. The housing member can have abottom surface and a top surface. The biasing member can bias theblocking member away from the bottom surface of the housing member. Thebiasing spring can be configured to rotationally bias the blockingmember to a first position relative to the housing member. The housingmember can include an exterior surface and an interior surface, whereinthe prosthesis retaining slots have an exterior opening opened to theexterior surface of the housing member and an interior opening opened tothe interior surface of the housing member. The blocking member can beconfigured to be movable between a first position wherein the blockingmember does not obstruct the interior opening of the prosthesisretaining slots and a second position wherein the blocking memberobstructs the interior opening of the prosthesis retaining slots. Theouter tube can obstruct the exterior opening of the prosthesis retainingslots.

Example 2

Another embodiment of the present invention provides a prosthesisretaining assembly for securing an implantable prosthesis to a catheterassembly. The prosthesis retaining assembly includes a valve retainerhaving a central lumen, the valve retainer having a top surface and abottom surface, wherein prosthesis retaining slots are formed in the topsurface. The prosthesis retaining assembly further includes a pluralityof walls extending from the top surface of the valve retainer, thespaces between the walls defining channels that are open to theprosthesis retaining slots. The prosthesis retaining assembly furtherincludes an outer tube, wherein the valve retainer is positioned insidethe outer tube. The prosthesis retaining slots are configured to retaina portion of a prosthesis therein.

The valve retainer can include an exterior surface and an interiorsurface, and the prosthesis retaining slots can have an exterior openingopened to the exterior surface of the valve retainer and an interioropening opened to the interior surface of the valve retainer. Thechannels defined by the walls can be configured to prevent a retainedportion of a prosthesis from exiting the interior opening of theprosthesis retaining slots. The outer tube can be slidable with respectto the valve retainer. The outer tube can be configured to assume afirst position that obstructs the exterior opening of the valveretainer.

Example 3

Another embodiment of the present invention provides a prosthesisretaining assembly for securing an implantable prosthesis to a catheterassembly. The prosthesis retaining assembly includes a blocking memberhaving a central lumen therethrough and a housing member connected tothe blocking member, wherein a plurality of prosthesis retaining slotsare formed in the housing member. The prosthesis retaining assemblyfurther includes a plurality of retaining rods and a biasing member,wherein the biasing member is configured to bias the retaining rods to afirst position corresponding to the position of the prosthesis retainingslots. The blocking member is positioned at least partially inside thehousing member. The prosthesis retaining slots are configured to retaina portion of a prosthesis therein.

The retaining rods can include a base, and wherein the base of theretaining rods can space the blocking member away from the biasingmember. The blocking member can include an outer surface and an interiorsurface, and wherein the prosthesis retaining slots have an exterioropening opened to the exterior surface of the blocking member and aninterior opening opened to the interior surface of the blocking member.When the retaining rods are in the first position, the retaining rodscan obstruct the interior opening of the prosthesis retaining slots. Theretaining rods can be configured to be movable to a second position thatdoes not obstruct the interior opening of the prosthesis retainingslots. The biasing member can include a silicon disk. The biasing membercan include a spring.

1-25. (canceled)
 26. A prosthesis retaining assembly for securing animplantable prosthesis to a catheter assembly, the prosthesis retainingassembly comprising: first member including, a central longitudinalaxis, a central lumen, a first end surface, a longitudinal passageradially offset from the central lumen, the longitudinal passageextending to the first end surface, a prosthesis retaining slotconfigured to retain a portion of the prosthesis, the retaining slotbeing configured to retain a portion of the prosthesis such that whenthe portion of the prosthesis is retained within the retaining slotlongitudinal movement of the prosthesis relative to the first member isprevented, the retaining slot having an inner opening intersecting withthe longitudinal passage and an outer opening intersecting with an outersurface of the first member; and a second member positioned within thelongitudinal passage of the first member, the second member beingmovable relative to the first member between a first position at which aportion of the second member is positioned adjacent to and obstructs aportion of the inner opening of the retaining slot preventing theportion of the prosthesis retained within the retaining slot fromexiting the inner opening of the retaining slot in a radially inwarddirection towards the central longitudinal axis, and a second positionat which the portion of the second member is moved relative to theretaining slot such that the portion of the prosthesis can pass throughthe inner opening of the retaining slot in a radially outward directionaway from the central longitudinal axis.
 27. The prosthesis retainingassembly of claim 26, wherein the second member is a rod.
 28. Theprosthesis retaining assembly of claim 27, wherein the second member isbiased to the first position.
 29. The prosthesis retaining assembly ofclaim 28, wherein the prosthesis retaining assembly is configured suchthat with the second member in the first position, the portion ofprosthesis may be inserted into the longitudinal passage at the firstend surface of the first member, and wherein pressure applied by theportion of the prosthesis against the second member overcomes the biasto move the second member towards the second position until the secondmember does not obstruct the inner opening of the retaining slot,thereby permitting the portion of the prosthesis to expand radiallyoutward through the inner opening of the retaining slot and into theretaining slot.
 30. The prosthesis retaining assembly of claim 29,further comprising an outer tube disposed radially around the firstmember, wherein the outer tube includes a first position blocking theouter opening of the retaining slot, thereby preventing the portion ofthe prosthesis from exiting the outer opening of the retaining slot. 31.The prosthesis retaining assembly of claim 30, wherein the outer tube isconfigured to be moved to a second position wherein the outer tube doesnot block the outer opening of the retainer slot, thereby enabling theportion of the prosthesis to self-expand radially outward through theouter opening during deployment of the prosthesis.
 32. The prosthesisretaining assembly of claim 27, further comprising: a ring, a portion ofthe ring disposed around a portion of the outer surface of the firstmember, the ring including a lip extending radially inward such that thesecond member is disposed between the lip of the ring and the first endsurface of the first member.
 33. The prosthesis retaining assembly ofclaim 32, wherein the longitudinal passage includes a second opening ata second end surface of the first member, wherein the second memberextends through the second opening, and wherein the second end surfaceof the first member is disposed longitudinally between the lip of thering and the first end surface of the first member.
 34. The prosthesisretaining assembly of claim 33, wherein the portion of the second memberis a first end portion of the second member, and wherein a second endportion of the second member opposite the first end portion extends outof the second opening of the longitudinal passage.
 35. The prosthesisretaining assembly of claim 34, wherein the second end portion of thesecond member has a larger cross-sectional profile than the secondopening of the longitudinal passage such that the second end portion ofthe second member is prevented from entering the longitudinal passagethrough the second opening of the longitudinal passage.
 36. Theprosthesis retaining assembly of claim 35, further comprising a biasingmember disposed between the second end of the second member and the lipof the ring, wherein biasing member biases the second member to thefirst position.
 37. The prosthesis retaining assembly of claim 36,wherein the biasing member is a disk, wherein the disk is compressibleand resilient.
 38. The prosthesis retaining assembly of claim 36,wherein the biasing member is a spring.
 14. 39. A method of coupling aprosthesis to a catheter assembly, the catheter assembly including avalve retainer disposed at a distal portion of the catheter assembly,the valve retainer comprising a first member defining a retaining slot,the retaining slot having an inner opening intersecting with alongitudinal passage of the first member radially offset from a centrallumen of the first member, and an outer opening intersecting with anouter surface of the first member, the method comprising: inserting aportion of the prosthesis into a first opening at a first end of thelongitudinal passage; applying pressure to the portion of the prosthesisto move a second member disposed in the longitudinal passage in alongitudinal direction away from the first opening until the secondmember does not block the inner opening of the retaining slot; andaligning the portion of the prosthesis with the inner opening of theretaining slot such that the portion of the prosthesis expands throughthe inner opening into the retaining slot.
 40. The method of claim 39,wherein the catheter assembly further includes an outer tube disposedradially outside the first member, wherein the method further comprisescovering the outer opening of the retaining slot with the outer tube toprevent the portion of the prosthesis from exiting the retaining slotthrough the outer opening of the retaining slot.
 41. The method of claim40, further comprising, after the step of aligning the portion of theprosthesis with the inner opening such that the portion of theprosthesis expands into the retaining slot, moving the second member ina longitudinal direction towards the first opening such that the secondmember blocks the inner opening of the retaining slot.
 42. The method ofclaim 41, wherein the second member is biased towards the first openingsuch that the step of moving the second member towards the first openingoccurs automatically when the portion of the prosthesis expands into theretaining slot.
 43. A method of coupling a prosthesis to a catheterassembly and deploying the prosthesis at a target site, the catheterassembly including a valve retainer disposed at a distal portion of thecatheter assembly, the valve retainer comprising a first member defininga retaining slot, the retaining slot having an inner openingintersecting with a longitudinal passage of the first member radiallyoffset from a central lumen of the first member, and an outer openingintersecting with an outer surface of the first member, the methodcomprising: covering the outer opening of the retaining slot with anouter tube; inserting a portion of the prosthesis into a first openingat a first end of the longitudinal passage; applying pressure to theportion of the prosthesis to move a second member disposed in thelongitudinal passage in a longitudinal direction away from the firstopening until the second member does not block the inner opening of theretaining slot; aligning the portion of the prosthesis with the inneropening of the retaining slot such that the portion of the prosthesisexpands through the inner opening into the retaining slot, wherein theportion of the prosthesis is prevent from exiting the outer opening ofthe retaining slot by the outer tube; advancing the outer tube distallyand radially compressing the prosthesis such that the prosthesis isdisposed within the outer tube in a radially compressed configuration;delivering the catheter assembly to a target site within the vasculatureof a patient; and deploying the prosthesis from the catheter assembly.44. The method of claim 43, wherein the step of deploying the prosthesiscomprises moving the outer tube to uncover the prosthesis, therebyenabling the prosthesis to self-expand.
 45. The method of claim 44,wherein the step of deploying the prosthesis further comprises movingthe outer tube such that the outer tube does not block the outer openingof the retaining slot, thereby enabling the portion of the prosthesis toself-expand out of the retaining slot through the outer opening of theretaining slot.